UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Title of the study (Brief title)	Clinical trial about safeness of perioperative blood glucose management using artificial pancreas in hepato-pancreato-biliary surgery
Region	Japan

Condition
Condition	1) Hepatectomy above 2 sectors 2) Pansreatoduodenectomy 3) Liver transplantation
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm safeness of erioperative blood glucose management using artificial pancreas after hepato-pancreato-biliary surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of hypoglycemia under 60mg/dL
Key secondary outcomes	1) Incidence of postoperative infectious complications during hospitalization 2) Stability of blood glucose level (target level: 80~110mg/dL) 3) Compalison of blood glucose accuracy between artificial pancreas and conventional method

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Blood glucose management using artificial pancreas (24 hours)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients received high invasive surgery. a) Hepatectomy above 2 sectors b) Pancreatoduodenectomy c) Liver transplantation 2) ECOG Performance Status Scale: 0~2. 3) Without active infection before surgery. 4) Age between 20y.o. to 80y.o. 5) Clean to clean-contaminated wound.
Key exclusion criteria	1) Case of other organ excision. 2) Case of pregnant, breast-feeding and possible pregnant woman. 3) ASA score over 4. 4) Other inadequate case judged by study participated doctor.
Target sample size	45

Research contact person
Name of lead principal investigator	Hiroyuki Takamura
Organization	Kanazawa University Hospital
Division name	Department of Hepato-Pancreato-Biliary and Transplant Surgery
Address	13-1, Takara-machi, Kanazawa
TEL	076-265-2362
Email	takamuh@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Hironori Hayashi
Organization	Kanazawa University Hospital
Division name	Department of Hepato-Pancreato-Biliary and Transplant Surgery
Address	13-1, Takara-machi, Kanazawa
TEL	076-265-2362
Homepage URL
Email	pwrofdrms2000@staff.kanazawa-u.ac.jp

Sponsor
Institute	Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

Funding Source
Organization	Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	金沢大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 03 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 05 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019108